Carboplatin, Vincristine, and Temozolomide in Treating Children With Progressive and/or Symptomatic Low-Grade Glioma - Full Text View

Sponsor:	Children's Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00077207

Purpose

RATIONALE: Drugs used in chemotherapy, such as carboplatin, vincristine, and temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.

PURPOSE: This pilot study is studying giving carboplatin and vincristine together with temozolomide in treating children with progressive and/or symptomatic low-grade glioma.

Condition	Intervention
Brain and Central Nervous System Tumors	Drug: carboplatin Drug: temozolomide Drug: vincristine sulfate

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	A Pilot Study Using Carboplatin, Vincristine And Temozolomide For Children ≤ 10 Years With Progressive/Symptomatic Low-Grade Gliomas

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Vincristine Carboplatin Temozolomide Vincristine sulfate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Feasibility of delivering this chemotherapy regimen at 24 and 60 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival at 3 years [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	July 2004
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Determine the feasibility and toxicity of an induction and maintenance regimen comprising carboplatin, vincristine, and temozolomide in children with progressive and/or symptomatic low-grade gliomas.

Secondary

Determine response rate in patients treated with this regimen.
Determine 3-year progression-free survival and overall survival of patients treated with this regimen.
Correlate response and progression-free survival with the genomic profile of tumors in patients treated with this regimen.

OUTLINE: This is a pilot study.

Induction therapy: Patients receive carboplatin IV over 1 hour on days 1, 8, 15, and 22; vincristine IV on days 1, 8, 15, 22, 29, and 36; and oral temozolomide on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy.
Maintenance therapy: Patients receive carboplatin and temozolomide as in induction therapy and vincristine IV on days 1, 8, and 15. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 30-50 patients will be accrued for this study within 2 years.

Eligibility

Ages Eligible for Study:	up to 10 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed progressive and/or symptomatic low-grade glioma, including any of the following:
- WHO grade I or II astrocytoma
- Grade I or II oligodendrogliomas
- Mixed oligodendrogliomas
- Gangliogliomas
Measurable disease
Progressive and/or symptomatic supratentorial or spinal cord tumors that cannot be removed for anatomical reasons are allowed
Optic pathway tumors allowed provided there is evidence of progressive disease by MRI and/or symptoms of deteriorating vision, progressive hypothalamic/pituitary dysfunction, or diencephalic syndrome
Dorsally exophytic brainstem gliomas that were previously resected more than 50% are allowed provided the residual tumor shows progression (with or without symptoms)
No diffuse brain stem tumors
No type 1 neurofibromatosis

PATIENT CHARACTERISTICS:

Age

10 and under

Performance status

ECOG 0-2
Lansky 50-100%

Life expectancy

Not specified

Hematopoietic

Hemoglobin ≥ 8.0 gm/dL
Absolute neutrophil count ≥ 1,000/mm^3
Platelet count ≥ 100,000/mm^3

Hepatic

Bilirubin ≤ 1.5 times upper limit of normal (ULN)
ALT < 2.5 times ULN

Renal

Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR
Creatinine ≤ 0.8 mg/dL (age 5 and under) OR ≤ 1.0 mg/dL (age 6 to10)

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 2 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

No concurrent immunomodulating agents

Chemotherapy

No other concurrent anticancer chemotherapy

Endocrine therapy

Prior corticosteroids allowed
No concurrent corticosteroids except for the treatment of increased intracranial pressure

Radiotherapy

Not specified

Surgery

See Disease Characteristics
Prior surgery allowed

Other

No other prior therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077207

Show 104 Study Locations

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Murali M. Chintagumpala, MD

Texas Children's Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Chintagumpala MM, Adesina A, Morriss MC, et al.: A pilot study using carboplatin, vincristine, and temozolomide for children with progressive/symptomatic low-grade glioma: A Children's Oncology Group (COG) study. [Abstract] J Clin Oncol 28 (Suppl 15): A-9539, 2010.

ClinicalTrials.gov Identifier:	NCT00077207 History of Changes
Other Study ID Numbers:	CDR0000350005, COG-ACNS0223
Study First Received:	February 10, 2004
Last Updated:	December 7, 2010
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

untreated childhood cerebellar astrocytoma
untreated childhood visual pathway and hypothalamic glioma
childhood spinal cord neoplasm
childhood oligodendroglioma
childhood low-grade cerebral astrocytoma

Additional relevant MeSH terms:

Glioma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Vincristine

Temozolomide
Dacarbazine
Carboplatin
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on February 09, 2012